Wellbeing/resilience in primary school children Not Applicable
Conditions
Interventions
The study comprises a randomised controlled feasibility pilot study of procedures for a trial comparing the CUES-Ed digital programme to a waitlist control group. The researchers also wish to estimate
a teacher-rated measure of class behaviour
and a child-rated quiz about the learning covered by CUES-Ed.
The design is a parallel-group feasibility cluster randomised controlled trial with random allocation of schools to one o
Sponsors
South London and Maudsley NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Schools: Local Authority run primary schools with Year 4 and Year 5 cohorts in England 2. Children: attending the school in Year 4 (aged 8-9 years)
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trial feasibility determined using: 1. Randomisation rate recorded as the number of schools randomised of those approached, recorded during the trial 2. Consent/assent and baseline data completion rate recorded as the number of children completing baseline with parental consent and child assent of those sent information sheets, recorded during the trial 3. Child assent rates recorded as the number of children assenting in each target class, recorded at their first assessment point 4. Follow-up rates recorded as the number of children completing outcomes at baseline and follow-up at 8 or 16 weeks 5. Adherence of teachers recorded as teacher delivery of the intervention, assessed by an observer at a single timepoint for each teacher using a bespoke measure to be developed during the pilot 6. Fidelity of intervention recorded as the number of schools randomised to receive intervention or control receiving the allocated condition, recorded throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Parameter estimation to determine the sample size for a full trial calculated using outcome data for the proposed primary clinical outcome measure (see below) 2. Validation of the classroom-based outcome measure (see below) by psychometric testing of collected data and comparison of teacher ratings to an observer rating conducted at a single timepoint for each teacher 3. Design and testing of teacher adherence ratings, conducted at a single timepoint for each teacher 4. Validation of the child quiz outcome measure (see below) by comparing collected data to standardised components and other study measures 5. Questionnaires/participant-completed measures are as follows: 5.1. Child emotional/behavioural problems will be measured by the proposed primary questionnaire outcome for the future RCT, the Me and My Feelings instrument comprising 16 items, each rated 0 (best) to 2 (worst), measuring emotional (M&MF-E) and behavioral (M&MF-B) difficulties (M&MF-E, ten items; borderline/clinical cut-off >9; M&MF-B, six items; borderline/clinical cut-off >5). The measure is designed specifically for use in schools to evaluate public health initiatives and has been widely used with children of this age group. The measure is completed at 0, 8 and 16 weeks. 5.2. Child wellbeing will be assessed by the proposed secondary questionnaire outcome for the future RCT, The Children’s Outcome Rating Scale (CORS). This measures wellbeing/distress across four items, each rated 0 (worst) to 10 (best); clinical cut-off <32. The measure is widely used with children of this age. The measure is completed at 0, 8 and 16 weeks. 5.3. Child resilience will be measured by a quiz assessing learning from CUES-Ed, which has been completed by large numbers of children during in-service delivery of CUES-Ed, so is acceptable for completion, with face validity. The researchers are in the process of | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Jolley
Outcome results
None listed